Text Messaging for HIV Prevention

Recruiting at 1 trial location

Overseen By Gabriel Federo Hungria, MD, MSCR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: HIV infection, Other HIV study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 months

266 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if text messages can help prevent HIV. Participants will receive either messages about HIV prevention (TM HIV) or general wellness tips. The study seeks dental clinic patients who speak English or Spanish and have at least one risk factor for HIV, such as having multiple sex partners or using intravenous drugs. Participants must be HIV-negative and comfortable using text messaging.

As an unphased trial, this study provides a unique opportunity to contribute to innovative prevention strategies and improve community health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on text messaging for HIV prevention, so it's unlikely that your current medications will be affected.

What prior data suggests that this text message-based intervention is safe for participants?

Research has shown that using text messages to help prevent HIV is generally safe and well-received. Studies have found that sending text messages to support HIV prevention and healthy behaviors does not cause significant negative effects. In past research, recipients of text messages for HIV prevention did not report any serious side effects.

For example, one study focused on using text messages to help prevent HIV during pregnancy and breastfeeding, and participants found the messages easy to handle. Another study examined the use of text messages to encourage HIV testing in teenagers and found no safety issues.

Overall, using text messages to prevent HIV is a safe way to share health information and promote preventive actions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using text messaging as a tool for HIV prevention, which is a unique and innovative approach. Unlike traditional methods that may involve face-to-face interventions or medication, these text messages are designed to be convenient, discreet, and accessible to a wide audience. The TM HIV messages specifically aim to reduce HIV risk and encourage testing, offering a personalized and direct form of communication. This approach could significantly enhance engagement and adherence to preventive measures, potentially reaching individuals who might not have access to or seek out conventional HIV prevention options.

What evidence suggests that this trial's text message interventions could be effective for HIV prevention?

Research has shown that text messaging can effectively help prevent HIV. In this trial, participants will be randomized into different arms to receive specific text message interventions. One arm, TM HIV, will receive messages designed to reduce HIV risk and promote testing. Another arm, TM HL, will receive messages promoting healthy living, but not specific to HIV risk or testing. A review of studies has found that sending text messages supports efforts to prevent and treat HIV. These messages can remind people to get tested and take preventive steps. Studies also show that text messages can encourage people to follow through with important health actions, like getting tested and taking medication. This method has improved health outcomes for people at risk of HIV by keeping them informed and involved in their health. ^{2 4 6 7 8}

Who Is on the Research Team?

Michelle Henshaw, DDS, MPH

Principal Investigator

Boston University Goldman School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking dental patients at certain health centers who have HIV risk factors like multiple sex partners, but are not HIV-positive. They must be able to give informed consent and commit to the study's duration.

Inclusion Criteria

Give informed consent and document consent via a signed and dated informed consent form in REDCap

Willing to comply with all study procedures and be available for the duration of the study

Be a dental clinic patient of record at one of our participating community health centers

Exclusion Criteria

Does not have a mobile phone or other device which can receive text messages from Agile Health

Does not have unlimited texting on their mobile plan

Has not used any type of text messaging at least once in the past month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Pilot

A feasibility pilot to test the text message delivery and study procedures

2 months

3 visits (self-report surveys at baseline, 1 month, and 2 months)

Treatment

Participants receive text messages regarding HIV prevention or overall wellness and complete self-report surveys

6 months

4 visits (self-report surveys at baseline, 3 months, 6 months, and 12 months)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (self-report surveys at 6 months and 12 months)

What Are the Treatments Tested in This Trial?

Interventions

• TM HIV
• TM HL

Trial Overview The study tests a text message program over three years. Participants will receive texts about either HIV prevention or general wellness. The goal is to see if these messages can help reduce the risk of getting HIV.

How Is the Trial Designed?

Group I: HIV text messages (TM HIV) Experimental Treatment 1 Intervention

Eligible participants randomized into this arm will receive text messages to reduce the risk for HIV and promote HIV testing.

Group II: TM HL Active Control 1 Intervention

Eligible participants randomized into this arm will receive text messages to promote healthy living, but not specific to HIV risk or testing..

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

A mobile text messaging intervention for HIV prevention was successfully implemented among 464 employees in the construction industry, achieving a high message delivery rate of 91.6% and 100% read rate, indicating strong engagement.

The intervention led to 21.6% of participants reporting they had taken an additional HIV test since the initial workplace testing, suggesting that SMS messaging can effectively promote HIV testing and awareness even during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test@Work Texts: Mobile Phone Messaging to Increase Awareness of HIV and HIV Testing in UK Construction Employees during the COVID-19 Pandemic. Middleton, M., Somerset, S., Evans, C., et al.[2020]

The Connect4Care (C4C) text messaging intervention did not significantly improve virologic suppression rates among HIV patients after 12 months, with 48.8% in the intervention group compared to 45.8% in the control group.

However, newly diagnosed patients showed higher suppression rates (78.3% vs 45.3%), and the study suggests that patient engagement through responses to text messages may be an important factor in achieving better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Christopoulos, KA., Riley, ED., Carrico, AW., et al.[2022]

The study demonstrated that text message surveys are a feasible method for assessing HIV-related economic and sexual risk behaviors among economically disadvantaged African-American young adults, with a 65% response rate from participants.

Participants showed a high engagement level, answering an average of 12.6 out of 14 questions each week, indicating that text messaging can effectively gather important data on sensitive topics like sexual health and economic behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Message Surveys in African-American Young Adults Experiencing Homelessness and Unemployment: Single-Group Study. Jennings Mayo-Wilson, L., Glass, NE., Labrique, A., et al.[2021]

A survey of 5,378 men who have sex with men (MSM) found that 49% of mobile phone owners were willing to receive text messages for an HIV-prevention study, indicating moderate interest in this intervention.

Willingness to receive text messages varied by demographics, with Black and Hispanic MSM showing more interest than White non-Hispanic MSM, and younger participants (under 22) being more receptive than older participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are MSM willing to SMS for HIV prevention? Khosropour, CM., Lake, JG., Sullivan, PS.[2022]

A review of 51 studies highlighted the importance of developing SMS content for mHealth initiatives aimed at supporting HIV/AIDS treatment adherence, emphasizing the need for formative research and grounding messages in behavior change theory.

Best practices for creating effective SMS messages include consulting with experts and using established behavior change frameworks to enhance the effectiveness of mobile health interventions in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content guidance for mobile phones short message service (SMS)-based antiretroviral therapy adherence and appointment reminders: a review of the literature. Kerrigan, A., Kaonga, NN., Tang, AM., et al.[2023]

Text messaging interventions have been shown to effectively improve adherence to antiretroviral therapy and increase appointment attendance among people living with HIV, based on a systematic review of nine high-quality reviews involving 37 studies across 19 countries.

There are significant knowledge gaps regarding long-term outcomes and patient satisfaction with text messaging interventions, indicating a need for further research to fully understand their impact and potential in managing other chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer. Mbuagbaw, L., Mursleen, S., Lytvyn, L., et al.[2022]

This study aims to analyze data from three randomized controlled trials involving text messaging interventions for improving adherence to antiretroviral therapy (ART) among people living with HIV, focusing on individual patient data from 2 Kenyan and 1 Cameroonian trial.

The meta-analysis will explore how factors like age, gender, education level, and duration on ART influence the effectiveness of text messaging, potentially identifying which patient groups benefit most from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone text messages for improving adherence to antiretroviral therapy (ART): a protocol for an individual patient data meta-analysis of randomised trials. Mbuagbaw, L., van der Kop, ML., Lester, RT., et al.[2022]

The SMS intervention for managing HIV Viral Load results in Zimbabwe was found to be acceptable to both patients and healthcare workers, improving adherence and management of results despite some implementation challenges.

While the intervention has the potential to reduce unnecessary clinic visits and enhance patient engagement in their HIV care, it requires clear communication and counseling to address concerns about message clarity and privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and health-care worker experiences of an HIV viral load intervention using SMS: A qualitative study. Venables, E., Ndlovu, Z., Munyaradzi, D., et al.[2020]

Text messaging interventions significantly improve adherence to antiretroviral therapy in people living with HIV, with an odds ratio of 1.39, indicating a notable increase compared to control conditions.

Interventions that are less frequent, allow for two-way communication, include personalized messages, and align with participants' medication schedules are particularly effective, also leading to improved viral load and CD4+ counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. Finitsis, DJ., Pellowski, JA., Johnson, BT.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6323863/

Effectiveness of text messaging interventions on prevention ... We conducted a meta-analysis to evaluate text messaging to support STI/HIV prevention and treatment interventions.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/77/NCT06088277/Prot_SAP_000.pdf

NIDCR Clinical Trial (Interventional) Protocol Template This study will test an interactive text messaging intervention to reduce HIV risk and promote testing: supporting both the diagnosis and ...

3. withpower.com withpower.com/trial/phase-hiv-infections-11-2023-529d0

Text Messaging for HIV Prevention Research shows that text messaging interventions can improve health outcomes for people living with HIV by promoting adherence to antiretroviral therapy (ART), ...

4. mhealth.jmir.org mhealth.jmir.org/2025/1/e57540

Effectiveness of an mHealth Intervention With Short Text ... The objective of this study is to evaluate the effectiveness of a mobile health (mHealth) intervention based on SMS text messages to increase antiretroviral ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329388/

Evaluating the Effectiveness of a Mobile HIV Prevention ... This study aims to determine the effectiveness of the Combine app to increase HIV testing, STI testing, and PrEP initiation among rural ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9926344/

A Text Messaging–Based Support Intervention to Enhance ... A text messaging–based support intervention to enhance pre-exposure prophylaxis for HIV prevention adherence during pregnancy and breastfeeding.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06096519

NCT06096519 | Effectiveness and Implementation of Text ... This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 year ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03666247

Mobile Messaging Intervention to Present New HIV ... The study will evaluate the use and effectiveness of mobile-messaging platforms as a public health strategy for improving sexual health outcome measures ...